What are the challenges when introducing a new companion diagnostic to clinical laboratories?
Development is a long and complex process, and in the UK, adoption can be very slow – it can take years before a test for an approved therapy sees widespread clinical use. There are many reasons for this, but in my opinion, the biggest obstacles fall into three categories:
- Time – Many sites want to perform their own studies on a new diagnostic, which, given the regulatory hurdles the therapy and test have already gone through, can unnecessarily duplicate efforts. Establishing external quality assurance, and ensuring training, validation and optimization of a test can take some time. Finally, allocation and wrangling over funding can delay uptake, too.
- Funding – In vitro diagnostics are not reimbursed in the UK, but instead funded through block contracts, or through national or local treatment tariff arrangements. Pathology is often seen as a cost, rather than being seen as adding value to medical decisions. But while only 2–3 percent of the total healthcare spend is made in this area, the vast majority of therapy decisions are made on the basis of test results. In the absence of a sustainable national framework for delivering companion diagnostics, pathology departments have to manage introduction of these relatively expensive tests within their existing budgets; this is a huge barrier to getting new treatments into the clinic. At the same time, failing to introduce these tests can result in costly and potentially unnecessary treatments for patients (Figure 1).
- Resources – Over the years, the role of pathologists seems to have become subservient to that of clinicians, and the balance of available resources between the two groups seems completely out of kilter. Pathology needs to be appropriately resourced, with a workforce skilled in both testing and interpretation, in order to be able to give clear information and direction on the application of therapies.
How can these issues be overcome?
In the US, we’re noticing that the FDA is starting to accelerate the approval of therapies with companion diagnostics, because of the clear benefits to patients of getting targeted therapies to market. Here in the UK, it is imperative that we put the appropriate framework in place to facilitate a similar rapid adoption.
Precision medicine heralds a new dawn in healthcare – and companion diagnostics are as critical to the application of precision medicine as the drugs themselves. This evolving area provides an opportunity to redefine the landscape, role and value of pathology, in particular histology. The time has come for pathologists to take the initiative, and to start leading these discussions – it would be great to see the Royal College of Pathologists proactively addressing these issues with their colleagues. Pathologists, clinicians, patient representatives, quality assurance schemes and finance departments all need to work together to provide a more balanced approach to the allocation of resources.
At Roche, I see our role as being both a strategic and operational partner to pathologists and laboratories. We already work closely with histology labs, supporting them with activities such as training, education, assay optimization and technical support. And providing the appropriate training is critical – medical practices are changing, and pathologists have to be prepared to accurately interpret increasingly complex results and advise clinicians accordingly. CADQAS and Poundbury have a clear mission to provide the training the pathology profession needs, and this is one of the reasons why we have chosen to work with them.
What benefits will Roche bring to PCI?
Roche has made a several year commitment, in the form of ongoing funding for the Institute’s work. We are providing instruments and reagents free of charge to PCI to help them undertake their work within the UK lab community. In addition, PCI has strong connections to our teams in Europe and the USA, where development of diagnostics takes place.
With the wave of new companion diagnostics getting ready to hit the UK, pathologists and labs need support. The chronic lack of pathologists, coupled with their ever-growing case workloads, means many of them simply don’t have the time to research multiple potential new approaches and their applications. PCI will help pathologists by educating and training them in the use of these techniques. Investigating where and how new tests will fit into treatment pathways is crucial, and by working with us early in the development cycle, PCI will have access to new companion diagnostics while they are still in development, and they in turn can prepare pathologists well in advance of the tests being released.
What does Roche gain?
This is the first such collaboration Roche has made in this area – the company will be watching closely to see how the relationship develops, as this could potentially become a blueprint for further similar projects. Our work with PCI and CADQAS will provide invaluable feedback on the process of bringing new companion diagnostics to the UK, including issues such as EQA schemes, training, and support needs. So far, getting new biomarkers and their corresponding tests into routine clinical practice has been slow. With the help of PCI, it should be possible to speed up adoption, benefiting our stakeholders and the NHS.
Is the NHS cautious of industry involvement?
I am always saddened when I hear members of the NHS refer to industry in less than glowing terms, but I can understand their point of view – not all companies are created equal, and a previous negative experience may be off-putting. But they shouldn’t let the actions of a few tarnish us all. I really don’t believe in an “us and them” culture – it’s not productive in the long-run. Industry needs the NHS, and the NHS needs industry. Although we may have some different viewpoints and perspectives, there are areas of common ground where we can easily work together to benefit patients. We won’t always agree, but with an honest, open dialog, I believe we can go far.
We are delighted to have been invited to work with PCI. This is the culmination of years of discussion, and we have high hopes for the future – PCI is a shining example of what can be achieved when the NHS and industry work together for the greater good.
By Corrado D’Arrigo
Poundbury Cancer Institute aims to put pathology at the forefront of cancer research, and bring industry, national healthcare service and quality assurance together to expand the use of companion diagnostics and important biological markers.
Keith Miller is Director and co-founder of CADQAS (Cancer Diagnostic Quality Assurance Services), a not-for-profit community interest company hosted by Poundbury Cancer Institute (PCI), which works to provide information and training to laboratory staff, and to ensure the quality of cancer diagnostics.
- Horizon Scanning Centre, “Trastuzumab (Herceptin) for HER2 positive early breast cancer – two year regimen”, (2012). Available at: bit.ly/1hFUccv. Accessed August 26, 2015.
I have an extensive academic background in the life sciences, having studied forensic biology and human medical genetics in my time at Strathclyde and Glasgow Universities. My research, data presentation and bioinformatics skills plus my ‘wet lab’ experience have been a superb grounding for my role as an Associate Editor at Texere Publishing. The job allows me to utilize my hard-learned academic skills and experience in my current position within an exciting and contemporary publishing company.